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Aurolife Pharma LLC

Reviewer, QC

Post Date:May 19, 2017Type:Full-Time
Start Date:5/19/2017Salary:
Location:US-NJ-Dayton, NJ 08810 Job Reference:
Skills:

JOB SUMMARY

Reviewer will perform primarily review of the day-to-day analytical testing data and related quality documents. The Reviewer may execute 90% - 100% of their work at the analytical data and/or documents. 


  1. Review of day-to-day Analytical data generated in the Laboratory. Maintains and up dates essential Laboratory documents as per current regulatory guidelines. Review and Compilation of Analytical Data required for Regulatory filings.
  2. Serves as department representative and/or technical lead at meetings. May lead and coordinate day-to-day activities of other chemists.  Participates in discussions and meetings for the purpose of exchanging ideas in relevant areas of interest.
  3. Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and/or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation.
  4. Demonstrates critical thinking skills and creativity when solving problems. Originates reports in written or oral form so that new ideas or approaches are brought to the attention of appropriate personnel.
  5. Participate periodically internal audits compliance to cGLP and cGMP in Analytical Lab.
  6. Compilation and trending of Analytical data.
  7. Review and preparation of SOPs, STPs, GTPs and Protocols.
  8. Review/ approval of sample login in LIMS and data migration


OTHER FUNCTIONS AND RESPONSIBILITIES

Perform other duties as assigned


QUALIFICATIONS
  • Minimum BS with Scientific field
  • BS with Chemistry is one of the subjects would be preferable
  • Minimum 5 or more years experience in pharmaceutical analytical lab and 1-2 experience in reviewing QC data.
  • Experience in Generic Pharmaceutical industries would be preferable
  • Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
  • Ability to learn quickly and decision making skills













Job Description:


A fantastic opportunity at Aurolife Pharma, LLC., a subsidiary of Aurobindo Pharma USA, Inc!

Aurolife Pharma, LLC is the manufacturing division of Aurobindo Pharma, a rapidly growing family of companies, with a consistent standing in the top 10 list of generic pharmaceutical companies, and ranked 6th among pharmaceutical companies based on Total Prescriptions Dispensed.

Not only have we received more ANDA approvals than any of our competitors, we have the lowest turnover rate of 2%, compared to an average if 19.2% among healthcare employers. 

An exciting opportunity to join our Research and Development team as a Formulation Scientist working on some of the industry's highest prescribed products. 

Pharmaceutical experience in the generic field is a strong requirement. All candidates are urged to review the requirements prior to the submission of their resume.






Contact Information
Aurolife Pharma LLC
Name: Elena Tolstikova
Ph: (732) 796-8702


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